Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3000279201

FEI Number

3000279201

Entity Name

Creation Technologies Ltd

City/State/Country

Burnaby British Columbia, CA

Establishment Address

8977-8999 Fraserton Court, Burnaby British Columbia V5J 5H8, CA

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CREATION TECHNOLOGIES Ltd (Owner Number: 9067426)

Owner / Operator Contact Address

8977-8999 Fraserton Court, --, BURNABY, B.C., CA-BC V5J 5H8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ALGO 5 PREAMP ALGO 5 DSP Olympic Papoose Board,Olympic Circumstraint LABSYSTEM PRO EP Recording System CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System Rhythmia Mapping System IntellaNav CB - Stockert Rhythmia HDx Ablation Connection Box for INTELLAGEN Rhythmia Mapping System IntellaNav CB - Maestro Rhythmia HDx Ablation Connection Box IntellaNav StablePoint for INTELLAGEN Rhythmia HDx Ablation Connection Box IntellaNav StablePoint with Maestro Force Sensing Breakout Box ECG OUT Box Rotablator Dynaglide Foot Pedal Algo 3i Rhythmia Mapping System, ECG Out Box and Cable Kit 1 US Rhythmia Mapping System, Connection Box - Maestro Rhythmia Mapping System, Connection Box - IBI Rhythmia Mapping System, Connection Box - Stockert Rhythmia Mapping System, ECG Box Out Rhythmia Mapping System, Conditioning Box neoBlue FARASTAR AAMI Recoding System Module ECG Output Module FARASTAR IEC Recording System Module ECG Output Module FFR Link Bluetooth Communication Module SMARTFREEZETM Inter-Connection Box(5-port) Smart FreezeTM Remote Control neoBLUE Radiometer,Olympic Bili-Meter NeoBlue NavPro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2017-05-09
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2021-12-10
FRP	Holder, Infant Position	General Hospital	Class 1	880.5680	2020-05-29
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2015-11-05
OAD	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	Unknown	Class 3	N/A	2017-05-09
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2017-03-31
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-05-20
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2019-05-02
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-02-21
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2016-03-11
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2007-12-05
QZI	Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	Unknown	Class 3	N/A	2024-02-05
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2015-11-04
OAE	Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	Unknown	Class 3	N/A	2023-09-14
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2020-09-01
LBI	Unit, Neonatal Phototherapy	General Hospital	Class 2	880.5700	2007-12-05
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2014-02-21
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2014-08-26
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2014-08-26

Official Correspondent

Geoffrey Lugtu

US Agent Details

Andrea Roether Email: andrea.roether@creationtech.com Phone: (847) 8338070

Related Public Records

Same Entity

CREATION TECHNOLOGIES Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935043	Siemens Medical Electronics	SIEMENS CLINICAL WORK STATION	1995-04-07
K170948	Acutus Medical, Inc.	AcQMap High Resolution Imaging and Mapping System	2017-10-16
K242016	ABBOTT MEDICAL	EnSite X EP System	2024-08-09
K172182	St. Jude Medical (Now Part of the Abbott Medical)	QUANTIEN Measurement System	2017-08-18
K252013	ABBOTT MEDICAL	EnSite X EP System	2025-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2016	Biosense Webster, Inc.	2	Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.
Z-0032-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 23 974.
Z-0033-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 633.
Z-0034-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 641
Z-0035-05	Siemens Medical Solutions USA, Inc	2	AXIOM Sensis Programmable diagnostic computer, Model number 66 34 658

Similar Registrations

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2184149	St. Jude Medical, Atrial Fibrillation Division, Inc.	Saint Paul, MN, US
2030404	IRVINE BIOMEDICAL. INC.	IRVINE, CA, US
9673241	BIOSENSE WEBSTER, INC.	JUAREZ Chihuahua, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3000279201. Last updated year: 2026. Please use registration number 3000279201 when referencing this establishment in official correspondence.